Skip to content
Triangle logo TriangleGet started
← Full study record

NCT01858558 · OUTCOME

Progression-free Survival (PFS)

Tadalafil and Lenalidomide Maintenance With or Without Activated Marrow Infiltrating Lymphocytes (MILs) in High Risk Myeloma · Source last updated 2020-06-29

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
months
Interval / dispersion
Inter-Quartile Range
Time frame
5 years

What was measured

Median PFS time equals the time of randomization (in months) until disease progression, death from any cause, or protocol deviation due to lenalidomide dosing (above 10mg), whichever occurs first.

Analysis population: This is an analysis by intention-to-treat and only considers transplanted patients randomized to the aMILs arm.

Groups in this outcome

aMIL Arm

Patients receive activated Marrow Infiltrating Lymphocytes (aMIL) aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
aMIL Arm70

Reported measurements

Source class 1
Values in months · Interval/dispersion: Inter-Quartile Range
GroupValueSpreadLowerUpperComment
aMIL Arm21.82Not reported18.5341.82Not reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        18.53
        upper Limit
        41.82
        value
        21.82
denoms
  1. counts
    1. group Id
      OG000
      value
      70
    units
    Participants
description
Median PFS time equals the time of randomization (in months) until disease progression, death from any cause, or protocol deviation due to lenalidomide dosing (above 10mg), whichever occurs first.
dispersion Type
Inter-Quartile Range
groups
  1. description
    Patients receive activated Marrow Infiltrating Lymphocytes (aMIL) aMIL: On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
    id
    OG000
    title
    aMIL Arm
param Type
MEDIAN
population Description
This is an analysis by intention-to-treat and only considers transplanted patients randomized to the aMILs arm.
reporting Status
POSTED
time Frame
5 years
title
Progression-free Survival (PFS)
type
SECONDARY
unit Of Measure
months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice